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Peyronies Disease TREATMENT Discussion Boards => Developmental Drugs & Treatments => Topic started by: hope794 on August 07, 2018, 06:24:44 PM

Title: Wake Forest- Good news
Post by: hope794 on August 07, 2018, 06:24:44 PM
Hi all.
In these days, i contacted Wake Forest University to know how their researches are going on.

I paste here to you the reply of Mrs. Mary-Clare:

Good afternoon Davide,

Thank you for your interest in our research.

We are about to begin a new clinical trial to replace damaged corporal tissue, primarily aimed at Peyronie's Disease.  More information regarding the study, including inclusion and exclusion criteria may be found here:

https://clinicaltrials.gov/ct2/show/NCT03463239

If you would like to schedule a consult appointment with the urologist in charge of the study, the phone number is 1-888-716-9253.  The urologist is Ryan Terlecki.

https://www.wakehealth.edu/Faculty/Terlecki-Ryan.htm

It appears that you may not live in the United States.  Because this studies requires follow-up for 3 years after surgery, it is important that the enrolled patients live within 2 hours of the hospital.
Please let me know if I can provide more information to you.


Thank you,
Mary-Clare


Here you can see another response from a collegue of Mrs Mary-Clare: (Mrs. Bonnie Davis)
Please notice that Mary-Clare replied to my email after Mrs Davis.


HI Davide –

Thank you for your inquiry regarding the Institute for Regenerative Medicine's research on penile tissue regeneration using cell and tissue engineering techniques. Although we are actively working in this area, our research is still in the experimental stage. We regret that this technology cannot be applied to clinical practice at this time, but there is hope for clinical trials in the near future. However, it is our goal to bring this technology to the point of widespread clinical use, and we hope to be able to help patients like you in the future.

We thank you for your interest in our work. We will keep your inquiry on record and contact you, if appropriate, in the future. (Please provide your full name, date of birth, address, phone number, and email so that we can contact you if needed.)

In the meantime, we encourage you to visit clinicaltrials.gov for the latest information on clinical studies related to your condition.

If you wish to seek any treatment for your condition in the meantime, we have a clinician in the Urology department who is an expert in men's sexual health and Peyronie's Disease.

Sincerely,
Bonnie Davis
Communication Manager
Wake Forest Institute for Regenerative Medicine
Title: Re: Wake Forest- Good news
Post by: tiagofil on August 07, 2018, 07:46:19 PM
,
Title: Re: Wake Forest- Good news
Post by: Jack1909 on August 08, 2018, 06:40:46 AM
I spoke with Terlecki less than a month ago. I was there, in North Carolina. Well I was told that their priority focus are veterans.
I don't why this Mary keeps on saying they are recruiting peyronies suffers as Terlecki told me they aren't. So either I was not properly informed or this Mary is wrong. As far as I understood this Mary speaks just on Terlecki's behalf...

I mean..something simply doesn't add up. A trial just for veterns suffering from Peyronies Disease sounds improbable..
Title: Re: Wake Forest- Good news
Post by: Jack1909 on August 08, 2018, 06:51:02 AM
"primary objective of this Armed Forces Institute for Regeneration Medicine (AFIRM II) sponsored clinical"

...that's what is written on the trial link
Title: Re: Wake Forest- Good news
Post by: swiss on August 08, 2018, 12:44:31 PM
We aren't on the inside of a constantly shifting narrative in a structured corporate setting. I hope it changed and they shifted gears! haha.
Title: Re: Wake Forest- Good news
Post by: hope794 on August 09, 2018, 10:01:13 AM
Dear friends, i'm happy that this post has attracted your attention. Unfortunately, since i'm not mothertongue, i had the same doubts as Jack.
I thought that the clinical trial that Mrs. Mary was talking about was the penile transplant for veterans.
But i think that she was referring to a totally new experiment, so i did some research.

If i understood well, THIS is the clinical trial for total penile transplant of the brave veterans which lost their genitals:

https://clinicaltrials.gov/ct2/show/NCT03240822

Instead, this is the clinical trials for Peyronie's and other deformities and penile issues, the one which Mrs. Mary was talkin about:

https://clinicaltrials.gov/ct2/show/NCT03463239

As you can see, they are different. The second one, it's not so far - a primary completion date will be in 2021 and the final date is 2022. So, not really far, it's only 4 years to go. What i asked to Mrs. Mary is if, after this experiment, the treatment will be available for the clinics, or this is only a "Phase 1" which will be followed by a "Phase 2" and a "Phase 3", even if i don't think that because this is not a "drug" but a "treatment", it's already tested on "humans" and, if this trial will give good results, there will be no need to do further trials.

I would be really grateful if someone which is mothertongue or has a PERFECT english can give a comment about these. For an italian which don't speak english everyday it's not really easy to read scientifical papers and clinical trials and understand everything perfectly. Thank you really much!!
Title: Re: Wake Forest- Good news
Post by: Werther on August 12, 2018, 11:01:38 AM
I've contacted WFIRM via e-mail several times since the beginning of this year and these are the last relevant information on their upcoming phase-1 clinical trial (at least, based on what I was answered after my iniquiries):

1) candidates' enrollment will begin in september;
2) candidates' enrollment could last "a couple of years";
3) once they'll have begun with the trial, it will last 36 months (follow up appointments included).

I'd also like to stress out that they don't intend to confirm that this intervention could solve ED, eliminate deformities or restore size; here's what I've been answered after I've asked them about these issues:

"Good afternoon,

The study procedure is not intended to help with ED.  It is intended to prove safety of this procedure and the feasibility of doing the biopsy and implantation of the cell coated scaffold to correct a small area of corporal defect.   I am not sure the procedure will solve your ED or restore size, but may correct some curvature, though we cannot say that since we are only approved by the FDA for safety results.

Regarding residency, subjects should live within an 2 hour drivable radius to participate in the study.

I  hope this information is helpful.

Thank you,


Mary-Clare
".
Title: Re: Wake Forest- Good news
Post by: DELETED on October 08, 2018, 09:31:00 AM
Quote from: Werther on August 12, 2018, 11:01:38 AM
1) candidates' enrollment will begin in september;
2) candidates' enrollment could last "a couple of years";
3) once they'll have begun with the trial, it will last 36 months (follow up appointments included).

So, "good news from Wake Forest" not as good as it's supposed to be? How long time will it take for all of these steps like patients enrollments, tests, safety approvals, FDA approval, etc.? 10 years? 20 years? More?
Title: Re: Wake Forest- Good news
Post by: james1947 on October 21, 2018, 09:52:07 AM
I will add my question to Alex question:
How many years after the trial (minimum 5 years) we will see results?
How many years later they will get approval from the FDA?
Legitimate questions, no?

James
Title: Re: Wake Forest- Good news
Post by: Werther on October 21, 2018, 12:59:51 PM
I can't tell for sure, but if timings for phase-1 is at least 5 years (as it seems, based on their staff's words), I bet they'll take much more than a decade in order to get this surgery approved by FDA. And we can't even know as of today if this surgery will only be approved to treat curvature or if it will get approval even for ED.

Personally I have only one single question: what's the reason why this forum community has done nothing (and is still doing nothing) in order to communicate officially with WFIRM with regards to this trial?

It's pretty obvious that this kind of surgery can be beneficial only for guys like us and nobody is going to urge WFIRM to speed this process apart from us, because we're the only ones who might be interested. Except for the letter that was sent more than a decade ago to Atala, I've never seen anything done anymore as the "Peyronie's Disease Society". We have no right to complain about their slowness since we've been practically contributing to it.
Title: Re: Wake Forest- Good news
Post by: hope794 on October 21, 2018, 06:22:14 PM
I totally agree with Werther! In the past, i've done many posts about "doing something" but no one cares.

Guys, seriously, some days it seems that you don't have Peyronie's.

And please don't tell me that no one does nothing because of the "shame". I think that it's way more humiliating to have Peyronie's and, if the society needs some signature or donation to keep its activity, i would do it and i won't care to leave my real name on those papers, if it can help.

Why i don't do this on my own then? Simple: i'm only 24 years old, i come from Italy and i have a crappy  english; furthermore, i have no financial resources since i don't work and not enough knowledge about this disease since i discovered it only some months ago.

Good luck to everyone and please let me know if you're going to do something concrete - i'm always on, brothers.
Title: Re: Wake Forest- Good news
Post by: Alibaba on October 21, 2018, 08:21:15 PM
I am familiar with HIV clinical trials having 2 friends that are researchers. 1 runs an entire research team.  Safety is always the first phase and a very narrow set of parameters to make sure nothing interferes with the trial. Very likely the safety phase will be be on individuals with no issues after animal phases have passed.  Each phase requires approval and in this case military review. That can add months between each phase. There is a review of the design of each phase and that can take months to write. Any issue can halt the program or trigger a complete redesign or rewrite of the project design. Both government, private party, and university financed trials are subject to financing. Someone cuts off the cash, it's over. Great strides are often made in medical science but it is a slow slow process.  Some program designs work excellent in animals or humanized animals but fall flat on their face in human trials, something I do not yet understand why and I have spent hours at a time discussing and bouncing theories back and forth with friends trying to figure out why. In the mean time, my suggestion is to to follow the trials wherever they go so you can share hope and ideas with others and if it is ultimately successful, share some more, but for those with issues here and now, go with the best currently available treatment you have at hand. Trials can often take 10 years or more. What shape will you be in 10 years of wait? What stress will you put yourself into to wait? Are you capable of keeping things in check without further deterioration to await the outcome of a trial?  I do not say these things to distress anyone but as being a person with a disease who has seen trial after trial start, fail, succeed, and promises of a cure never materialize in 30 years. Support every trial you can. Encourage the researchers. I know my researcher friends get very weary of the long hours they put into their projects and letting them know you appreciate what they do helps, but be realistic with yourself comparing the timetable of a trial and the timetable of your life. Cheers to men who strive to become boys again.
Title: Re: Wake Forest- Good news
Post by: Jack1909 on October 22, 2018, 07:24:01 AM
In my humble opinion, no one should loook at wake forest university work anymore...it will take forever before this will eventually be a available for everyone. They are focusing on military people, not us..that's the prime reason why we should just turn around..
Anyway, phase 1, 2, 3 here works different than usual here as we are talking about a surgical procedure implying a grafting placed inside the body rather than a drug.

We might, as a group, find a research team placed in countries where people can go experimental if they want to..that's might be a game changer. There is plenty of resaerchers from so many country which are working on tissue replacement and I would sign up immediately for any trial procedure which has got some reasonable background. Wake Forest doesn't have any exclusive...
Title: Re: Wake Forest- Good news
Post by: hope794 on October 23, 2018, 07:15:45 AM
@Alibaba: thank you for your comment, it was great and i totally agree.

@Jack: unfortunately i think you're right. One day there will be a solution for Peyronie's disease, but i think we are still far far away.
For now, i would be happy if they find a solution for venous leak, since my main issue are the erections. My bend is about 10° so it's not an issue, but the ED for a 24years old guys is seriously the hell, a never ending curse.
Title: Re: Wake Forest- Good news
Post by: DELETED on October 23, 2018, 08:39:16 AM
All of the comments in this thread are truly depressive and leading to suicide thoughts. What's the "good news"? The good news is to realise that it will not be possible for the nearest 30 years? Or good news in terms of: "The future generations of people will not have this problem as we face it now"? Oh well, this is a good news, right. But you forgot to add that most of us would be dead at the moment of time when the technology will be available. Name of this thread should be: "Good news for all who will be born after year 2050".
Title: Re: Wake Forest- Good news
Post by: Jack1909 on October 24, 2018, 02:01:22 AM
I don't think it will take so long if we commit ourselves in finding "other places"...we should try, putting together our knowledge and our desire to see our life change....recently I put my eyes on Japan (as the result of its favorable legislation in terms of accessibility of regenerative treatments).

The point is...are you willing to sign up for an experimental procedure?? I would...

What baffles me is the fact we are talking about a tiny tissue structure replacement...there are people around the world involved in far more complex regenerative procedures...
Title: Re: Wake Forest- Good news
Post by: Werther on October 24, 2018, 03:18:57 AM
Jack,

I agree with you on the fact that WFIRM has not any exclusive right on tissue engineering. This is not the main problem however. The fact is that we as a group don't do anything ever in order to communicate with researchers who might be working on something useful for us. That's why every developmental procedure (and there's very little for peyronie's disease or penile fibrosis more generally) takes literally ages to progress.

I'd be very glad to open up to other research groups but we should first know who they are. Could you please post a link here of the japanese's research team or others you know about that are dealing with penile erectile tissue bioengineering? Then, if we truly want to do something, I'd be very glad to get involved in any activity that could lead us to show our genuine interest (mass mail projects, donations or whatever). This is what should be done and PDS has never done it in the past. With regards to Atala, a letter was sent on the 23 of July 2010, it got no response and he wasn't solicited further (look here: Letter To Dr. Atala (Tissue Engineering) - Peyronies Society Forums (https://www.peyroniesforum.net/index.php/topic,1227.0.html)); there's no wonder if they're only getting started by now (more than 8 years later!).

Title: Re: Wake Forest- Good news
Post by: hope794 on October 24, 2018, 02:31:03 PM
I agree with Werther. Furthermore, i would like to say that probably the people who are english mothertongue and live in USA have got more responsability in this matter, because they may take part of any experiment and have no troubles to communicate with scientists.
Personally, i asked to WFIRM if i could take part of the clinical trial, but they said to me that i'm too far away from them ( i think that you have to live near their research center, at a maximum of 2 hours of travel from them) and i could not partecipate since my english is not high level and i may have some troubles to describe with high precision to them any issue or symptom.

I've done EVERYTHING i could. I am trying a cure by MD Gianni Paulis, a doctor in Italy who says that he can ameliorate Peyronie's disease and, in some cases, let the plaque disappear. He says that i'm one of these cases..Let's see. I'll keep you updated.
Please, brothers from USA, do something!! As i said, if you need any support from other countries, like signatures for projects, or donations or anything else, i am sure that you'll find support from all over the world.
Title: Re: Wake Forest- Good news
Post by: Jack1909 on October 25, 2018, 12:59:51 AM
Yeah the fact we live abroad is a problem I was told the same...that's  why I told them I would move to North Carolina LOL 
Title: Re: Wake Forest- Good news
Post by: DELETED on October 25, 2018, 03:13:07 PM
It's seems like besides me and 3 Italian guys no one else is interested in this. What an irony: people who live on the other side of the Earth are interested in this more than someone who lives near NC or in NC.
Title: Re: Wake Forest- Good news
Post by: P1992 on October 25, 2018, 04:55:25 PM
AlexSamo,

I think many here have an interest and I am one of them, but we can not participate because we are excluded by the very rules of wake forest? In case the distance.
Title: Re: Wake Forest- Good news
Post by: Jack1909 on October 26, 2018, 12:42:30 AM
Yes Alex, that's ridiculous...maybe American know how much Ugly NC is..LOL worst place I've seen in earth so far LOL
Title: Re: Wake Forest- Good news
Post by: TDix on October 26, 2018, 03:11:37 AM
I've been following this, and I'll say that even the manufacturer of Xiaflex, who found out about my problems, seem to not be interested in my reaction.  I have been waiting to talk with them but it's been silent. I would hate to think that we are all a group that generates money at the expense of our well being for the drug companies/implant companies/VED companies/traction companies.  I just want a healthy d*ck man!  Seems a long way off for some of us
Title: Re: Wake Forest- Good news
Post by: Hawk on October 26, 2018, 08:22:29 AM
Quote from: Jack1909 on October 26, 2018, 12:42:30 AM
maybe American know how much Ugly NC is..LOL worst place I've seen in earth so far LOL
:) I have been in more than a few countries and 35 states.  I pass through NC a couple times a year (probably well over 100 times).  I would rate it as a great state with beaches, cities, forested mountains, and a little something for everyone. 
Title: Re: Wake Forest- Good news
Post by: Werther on October 26, 2018, 08:40:23 AM
I'm wondering: is there any US resident here who's willing to go down there and talk face to face with the people who's working on this trial in order to make things clear with regards to it and report to the forum?

If we can speak directly, we could clarify a lot of things, such as how long will the entire process (all phases of the trial) last approximately and if anyone can do anything to speed it up (solicit the government or anyone who's getting this thing funded, etc.). As long as we send e-mails, we'll never know anything concrete, since they basically dismiss all the important inquiries on the subject.

The fact than nobody seems to give a F~@< about this annoys the crap out of me and based on the previous posts in this thread it looks like I'm not the only one who feels like this.
Title: Re: Wake Forest- Good news
Post by: Hawk on October 26, 2018, 09:04:43 AM
It seems like a phone call would be just as productive.  I have not followed this closely since it involved studies that will either succeed or fail many years in the future.  I personally doubt that any of this is slowed down by a lack of volunteers.  These things are painfully slow for reasons Alibaba pointed out.

If these people are willing to talk, I am happy to call them.  In fact I think we had a member of our PDS team that was in contact with them many years ago and who visited them in person.

Before I would attempt to contact them I need to understand the issues and a clear set of questions.  I also pass near that area a couple times a year but as I said, I think phone calls would accomplish as much as a visit.

PS: i think one has to consider current proven solutions.  I consider the implant in my penis a far far more important issue than something that has only a chance at success that will not be known for over a decade.  To anyone with ED, there is a great solution now.
Title: Re: Wake Forest- Good news
Post by: Werther on October 26, 2018, 12:49:55 PM
Hawk,

I got Alibaba's point and I agree with him, but I have to agree with Jack too: this trial is about a surgical procedure and my thinking is that there should be less obstacles and less time to spend to complete the whole procedure compared with trials whose goal is to test drugs... In this case there will be no control group after phase 1 if it's successful and this is for example a single reason why it should be quickier than trials dealing with drugs (I think that with regards to the latters, timespans could be longer because during the process researchers could reconsider dosages, composition of the drugs and lots of other variables that don't come up with surgical procedures).

Anyway, I keep thinking that being there in person and talking face to face with anyone who might answer what's relevant would be way better than talking on the phone. I speak by personal experience: I had trouble lots of times while contacting hospitals via phone... Once the person you're looking for is not avalaible, then some questions can't be answered by the person you're talking with, because you'd have to speak with colleague who isn't avalaible at the moment, etc. It's easy to be dismissed this way, even if the communication is clearly more direct than the one you can have via e-mail.

However I really appreciate your offer and if nobody is willing to go there I'd like you to call them to ask them some precise questions (better than nothing). If anybody here would like to submit what they want to ask them, we could form some sort of list and then you can report back to us what answers you received. Let's see if others here agree with this.
Title: Re: Wake Forest- Good news
Post by: suicidecomingsoon on October 26, 2018, 01:13:29 PM
Jack was there in person, it will be a long time before something from this institution can help us.
As Jack said it is better to look elsewhere, this looks like it will take 10-15 years to reach some conclusion, maybe 20 to be available if it comes out ok


This has been discussed for almost 10 years in this forum, at that time they could re-create cavernous bodies, spend another ten years and the thing will not have advanced much I suspect

In 2010:

"Hey Guys – My name is Ken and this is my first post on the site. I'm 48 years old and was diagnosed with Peyronies in 1989 therefore I'm encouraged by some of the advances that are on the horizon such as tissue regeneration. Tissue engineering technology is here today! The technology exists today to fabricate and replace a complete corpora cavernosa using your own cells thus eliminating any tissue rejection issues. I base my statement on the following:

1.  Dr. Atala and his team from Wake Forest Institute for Regenerative Medicine has fabricated and surgically implanted functional Corpora Cavernosum into rabbits. The corpora cavernosum were generated by building a scaffold and spraying the scaffold with the smooth muscle and endothelial cells, and then allowed to grow. The new rabbit penises are functional and operated well.
2.   Dr. Atala's team has been surgically implanting functional bladders into humans for the past four years, thus reducing some of the learning curve associated with human subjects and tissue engineering.
3.   Dr. Badylak from the McGown Institute of Regenerative Medicine has a different approach to regenerating body parts. His team uses a substance called ECM, Extra Cellular Matrix, extracted from pig bladders. The substance is places on the injured body part and it provides signals and instructions to jolt the cells into regenerating themselves. Amazing"


I think, maybe it's not a bad idea to contact to Dr. Badylak instead Atala?
Title: Re: Wake Forest- Good news
Post by: Hawk on October 26, 2018, 01:19:38 PM
Thanks for the post to put this in perspective.  I recall this for almost as long as we have had a forum and though I have not followed it in the last few years my impression was that we are not much further along.
Title: Re: Wake Forest- Good news
Post by: Jack1909 on October 27, 2018, 07:37:26 PM
I did my very best to get some insight into the matter but I was rejected and I couldn't grasp all the info I'd like to. They weren't so open up on it and honestly I don't want to be involved with anything having to do with wake forest anymore. I wasn't treated the way a person coming from the other part of the world would expect...anyway, Terlecki is the principal investigator of these trials, but you might need to arrange a consultation to have the chance to get in touch with him...

My hope is that the technology will spread soon in countries in which if you want to go experimental you are free to do it. Wake forest can go to hell...

Comment on implants moved by the Administrator with a long string of off topic implant posts.
Title: Re: Wake Forest- Good news
Post by: Alibaba on October 29, 2018, 11:46:52 AM
Quote from: Jack1909 on October 29, 2018, 03:40:01 AM

Dont you think is logically, if not medically, correct to me exploring every single option

Logic says 2 important things.

1) Most of these experiments go on for decades before available to the public and many are unaffordable or covered by insurance for a time after that.

2) Time wasted (waiting) equals lost function, pleasure, length and progression of disease.

Support all research. Encourage your researchers. Use logic and be realistic.
Title: Re: Wake Forest- Good news
Post by: DELETED on November 01, 2018, 09:06:21 AM
Quote from: Werther on October 21, 2018, 12:59:51 PM

It's pretty obvious that this kind of surgery can be beneficial only for guys like us and nobody is going to urge WFIRM to speed this process apart from us, because we're the only ones who might be interested.

I have to disagree with you on this. You think only people with Peyronies Disease will have benefit from this? Let me list other "groups" of people which are waiting (and need it) not less than we are:

1. People with Peyronies Disease (obviously)
2. People with erectile dysfunction
3. People with micropenis
4. People with small penis (not micropenis but smaller than statistical norms) who wants (and who have medical reasons for this) to increase size of the penis, but they can't do this because there are no legit procedures at the present time
5. People with injured/damaged penis
6. People who underwent invasive surgeries such as radical prostatectomy and other similar surgeries
7. People with penile/cavernous fibrosis
8. People who were born with epispadias/hypospadias and other inborn penile defects.
9. People after total penile amputation due to different reasons (injury, cancer, etc.)
10. Transsexual people (FtM), but I'm not sure if they will able to have such procedure because they originally don't have specific cells in their bodies.

That's not all "list" I guess. There are probably many others who will have benefit and who wait for this technology while having no alternative options at present time.

P.S. I don't get just one thing. This project of "penile tissue engineering" (or experiments, tests, trials, or whatever it's called) now is close to 30 years mark. Is this not enough time for creating something?! If they keep doing this work so slow, it will definitely reach a 50-year mark. Half-century for just one subject?! Even things like atomic reactors and space flights have taken much smaller timeline for humanity than creating a small pieces of penile tissues. This is ridiculous.
Title: Re: Wake Forest- Good news
Post by: hope794 on November 01, 2018, 09:53:20 AM
I totally agree with Alex. As i said: if any english-native speaker (better if american) wants to begin seriously to do something, i'm totally ALL-IN.
Title: Re: Wake Forest- Good news
Post by: Hawk on November 01, 2018, 11:09:42 AM
At one time we had a couple men who volunteered and worked exclusively on Public Outreach and Awareness.  It was a very adventurous plan for a loosely knit volunteer group.  We had so much going on that I an others worked huge amounts of their days.  I seldom got out of reach of the PC or iPad in those days.  It was not uncommon to put in 18 hours on Peyronies Disease issues.  Maintaining that level with casual volunteers is not easy.  People burn out and go their way.  Over the many years, I have worked with great men and women.  Some had connections in the right places, many had great skills, they all had a desire to serve others but they also had other life issues that pulled them away. We try to replace them but the challenge requires finding the right match.  It is not easy to find someone with the 1. people/professional skills, 2. Passion, and 3. the time to do what is necessary.  We have many people with one or two of those but it takes all three. 

I no longer have the time to stay at the keyboard day in and day out.  That makes it difficult to recruit others that are willing or able to do that. 
Title: Re: Wake Forest- Good news
Post by: Werther on November 01, 2018, 05:28:55 PM
It takes very little time and no money at all to sign up a petiton. This is my opinion at least.
Title: Re: Wake Forest- Good news
Post by: Werther on November 02, 2018, 05:51:31 AM
I personally don't feel like having attacked anyone, staff members included. Unless you think that it's an attack asking for an opinion about a petition or anything that could spread awareness or help speeding up trials that could be useful for every man with penile fibrosis and ED, but I don't see what would be the logic behind such a statement.

To answer directly your question, I'd personally try my best to get involved in this phase1 trial that is about to begin in the very next few years (no decades, just a couple of years at worst), but I won't do it since the main investigator didn't intend to confirm in any way that this first intervention could be beneificial for ED. Based on this assumption, I'd like to wait for the results of this first phase and then do the best I can in order to get involved in phase2 if good results will be reported from the previous one. And I won't have to wait for 15 years at the very least in order to get these things done. Maybe I wouldn't have to wait for 5 years neither if we could make ourselves being heard by these people. Hence I'd appreciate very much if we'd actively do something on this front and that's why I've talked about petitions and advocacy in my last posts. You're right on one point though: this Wake Forest experiment might even not work, but won't there be an implant as a last resort if this surgery failed as everybody say? If so, why bother on some people's choice to try something experimental before getting the life (non reversible) decision to get implanted?

With regards to the denial's rant let me just say that it's not a problem of mine. I know how things are with regards to ED and everybody does (even wikipedia is sufficient for this kind of info)... Then, I don't mean no offence but you've been aurond here and other ED forums for years and you've always looked comfortbale with implants based on your posts, so why didn't you get one and you're still not getting it? It looks like you're the one living in denial rather than me or others here...
Title: Re: Wake Forest- Good news
Post by: Hawk on November 04, 2018, 02:04:50 PM
I split off all the all the posts on the implant debate and moved them to the implant topic of the ED forum.  Here is the link for any interested.


Wake Forest- Vs Implant - Peyronies Society Forums (https://www.peyroniesforum.net/index.php?topic=10983.0)
Title: Re: Wake Forest- Good news
Post by: Werther on November 11, 2018, 04:21:46 PM
@everybody: Hawk kindly offered himself to go to WFIRM or call them via phone to ask them any relevant question that might clarify things we don't know about this trial. I have some questions and I'm going to post them here. If anyobody else would like to ask something else, he can do it right here.

Here are my questions:

1. Why does candidates' enrolment for this phase-1 study has to take at least 2 years? What's the reason behind this choice? Is it like this because of the FDA or is it a WFIRM's personal choice? Can anyone do something about it in order to reduce the timeline expected for closing candidates' enrolment for this phase of the clinical trial? If so, what can be done concretely?

2. Will WFIRM confirm that their experimental surgery aim to solve ED, deformities, curvature and size loss that are linked to peyronie's disease or, more generally, erectile tissue's fibrosis? If they don't intend to confirm it with regards to their phase-1 study - since it's only a safety study - are they going to confirm it at least for phase-2? In other words, what's the aim of the whole trial? Do they want to solve any side effect of erectile tissue's fibrosis with their intervention (ED and shaft's deformities included)?

3. What about the "whole penis development"'s project? WFIRM announced to the media that they were able to create "half a dozen human penises" back in 2014 (here's the link: https://www.theguardian.com/education/2014/oct/04/penis-transplants-anthony-atala-interview) but they're taking forever just to replace small parts of erectile tissue? Will they ever be able to bioengineer the whole organ? And why did they say that they've already done it in the lab? Is it true or was it just some fake news made up for the press?

4. Does WFIRM have an approximate timeline with deadlines for the whole trial? Can they estimate when will they begin phase-2 and phase-3 and when they'll be completely finished with this?

That's all for now. I'll add something new if I'll come to think about it.

@Hawk: I don't know if this post belongs here or if it deserves its own thread: please move it on a new thread if you think it's necessary.
Title: Re: Wake Forest- Good news
Post by: james1947 on November 13, 2018, 02:07:37 AM
Good questions Werther :)
Hope they will be willing to answer them.
They didn't answer my questions some 5 years ago.

James
Title: Re: Wake Forest- Good news
Post by: DELETED on November 15, 2018, 12:30:50 PM
Quote from: Werther on November 11, 2018, 04:21:46 PM
@everybody: Hawk kindly offered himself to go to WFIRM or call them via phone to ask them any relevant question that might clarify things we don't know about this trial.


Werther, thank you. Special thanks to Hawk.

Well, I have a lot of questions, but one question is the most important.

Here's my question to Wake Forest: How many years will it take for all of the tests, trials and approvals before this technology finally will be available in clinical practice? Is there something like approximate timeline, like 5 years, 10 years, 20 years? That's my only question. Thanks.
Title: Re: Wake Forest- Good news
Post by: Hawk on November 30, 2018, 04:41:29 PM
I made an email contact with Wake Forest 4 or 5 years ago with no response.  I intend to be a little more persistent this time.

Does anyone on the forum have any contacts there, or can anyone give me any information that might help me reach a useful contact a little more quickly? If not I will call the main number and start from there although that is less likely to be very efficient or productive, I assume I will start with the Wake Forest Institute for Regenerative Medicine (WFIRM) rather than the urology department. 
Title: Re: Wake Forest- Good news
Post by: Werther on December 01, 2018, 10:03:26 AM
I think you should call Mary-Clare Day (the Research Nurse Manager who poses as a referral for this trial): her number is 336-713-1343 (source: https://clinicaltrials.gov/ct2/show/NCT03463239). The main investigator of the trial is Dr. Ryan Terlecki and the sub-investigator is Dr. James Yoo but unfortunately I couldn't find any phone contacts of these but I have Dr. Terlecki's personal secretary (Pam Gippert)'s phone number and perhaps it might be worth calling her too: her number is 336-716-5690.

Anyhow I'd like you to ask them a few more questions in addition to the ones that I posted before (i'm formulating these via progressive numeration considering the previous ones):

5. What kind of adverse events do they think can happen with this experimental procedure? Are they able to provide a full list of possible adverse events?

6. What are the causes of the constant delays of their trial? I was once told by Ms. Day that they had to begin with enrolment last May, then - after another email's contact - she told me that they would have begun enrolling people by June or July; now I'm reading on clinicaltrials.gov that they're not recruiting yet. What's the reason for this? When are they finally going to recruit candidates?

Thank you for your help.

I hope to see some updates.
Title: Re: Wake Forest- Good news
Post by: Hawk on December 01, 2018, 11:13:49 AM
Werther,

In preparing for this contact I think we have good questions and a good start on initial contact info.  Thanks for your help.  This week I watched some clips of Dr. Terlecki and Dr. Atala that I had not seen before.  I would think Dr. Atala's office would also be a good possible contact.  Is there a reason you did not mention him?

Also, you mention your prior contact with at least Ms.Day.  Did you mention the forum at that time?  How were you generally received what was the reason you had no further contact?
Title: Re: Wake Forest- Good news
Post by: Werther on December 01, 2018, 12:56:44 PM
I did not mention this forum any time I contacted them ever. I always asked questions on my behalf. I'd be glad if you'll make clear to them that you're reaching out to them as a representative of a group (this forum). This way we could maybe get more understanding and consideration.

I had no further contact with Ms. Day because I was practically told to get there in person to get evaluated in order to estabilish my possible eligibilty for the trial. Besides, I only spoke with her via e-mail since I don't live in the USA. I'd rather have called them or been there in person by myself if I lived in the United States. Unfortunately I don't and that's why your offer to get in touch with them more directly is greatly appreciated. At least from my point of view.

I thought about getting in touch directly with Atala too, but he's not mentioned in the record that Wake Forest submitted on clinicaltrials.gov. Besides I don't have any contact of his (except for his office's e-mail: I once wrote to that account but I didn't get any response back). He could may well be a good contact, since he appears to be the guy who first thought about the concept that stands behind this clinical trial, but I don't know how can you directly talk to him.
Title: Re: Wake Forest- Good news
Post by: DELETED on December 01, 2018, 02:21:39 PM
Wake Forest's secretary M.C.Day: mday@wakehealth.edu


Other Wake Forest's secretary: tbowen@wakehealth.edu, krchrdsn@wakehealth.edu, marbeck@wakehealth.edu


Dr. Ryan Terlecki: Ryan Terlecki | Profiles RNS (http://profiles.wakehealth.edu/display/Person/rterlecki) (email: rterlecki@wakehealth.edu, phone number: (336) 713-4131)


Dr. James Yoo: James Yoo | Profiles RNS (http://profiles.wakehealth.edu/display/Person/jyoo) (email: jyoo@wakehealth.edu, phone number: (336) 713-7294)


Dr. Anthony Atala: Anthony Atala | Profiles RNS (http://profiles.wakehealth.edu/display/Person/aatala) (email: aatala@wakehealth.edu, phone number: (336) 716-5701)


Wake Forest Department of Urology Research: https://school.wakehealth.edu/Departments/Urology/Urology-Research


Wake Forest Institute for Regenerative Medicine (WFIRM): https://school.wakehealth.edu/Research/Institutes-and-Centers/Wake-Forest-Institute-for-Regenerative-Medicine
Title: Re: Wake Forest- Good news
Post by: DELETED on December 05, 2018, 12:22:35 PM
Werther,
Hawk,

I hope this information will be helpful
Title: Re: Wake Forest- Good news
Post by: Jack1909 on December 05, 2018, 02:40:20 PM
Ayala is soemoene who can't be reached out, he's a like a vip or as if you wanted to speak with the president of US.

Marie Whatever said you to come and be assessed just to get some money out of you. There is no chance to be envolved in any of the trials they proprose.

In the meanwhile, in Japan this December the first spinal cord regnerative treatment will be available for everyone. Kind of funny .
Title: Re: Wake Forest- Good news
Post by: hope794 on December 06, 2018, 06:53:20 PM
Hello guys, any news?
Title: Re: Wake Forest- Good news
Post by: Hawk on December 11, 2018, 03:36:02 PM
I called both  Mary-Clare Day (the Research Nurse Manager who poses as a referral for this trial) and Dr. Terlecki's personal secretary (Pam Gippert) today and left a voicemail for each of them.  Hopefully, I will have live contact sometime this week.
Title: Re: Wake Forest- Good news
Post by: DELETED on December 12, 2018, 12:27:31 PM
Quote from: Hawk on December 11, 2018, 03:36:02 PM
Hopefully, I will have live contact sometime this week.

Thanks, Hawk!

If you will be able to ask some of the questions, please, ask them my only one question: "How many years will it take for all of the tests, trials and approvals, before this technology finally will be available in clinical practice? Is there something like approximate timeline, like 5 years, 10 years, 20 years?"
Title: Re: Wake Forest- Good news
Post by: Hawk on December 14, 2018, 02:20:44 PM
Pam Gippert, Dr. Terllecki' personal secretary returned my call,  I have not heard back from Mary-Clare Day at this point.  Pam Gippert seemed unaware of any trial information and said that Dr. Terlecki is out of the country this week. She was very friendly and did give me her email address.  She volunteered that she would give my message to him when he returns.

I wrote an email introducing myself and the forum and posed all the questions we formulated.

I think I will still attempt to reach out to Mary Clare-Day and Dr. Atala's offices again next week.

I will keep you posted.

Hawk
Title: Re: Wake Forest- Good news
Post by: popopo on December 16, 2018, 06:44:10 AM
Thank you for keeping us updated. I'll stick around this topic, cause I still feel like Regenerative medicine is the way to go for me in the future.
Title: Re: Wake Forest- Good news
Post by: DELETED on December 17, 2018, 10:16:57 AM
Thanks Hawk! Keep us updated.
Title: Re: Wake Forest- Good news
Post by: Werther on December 22, 2018, 10:35:50 AM
Hawk,

did you get any response back from Terlecki, Mary Clare-Day and Atala during the week?

Title: Re: Wake Forest- Good news
Post by: Hawk on December 23, 2018, 09:04:10 PM
Yes, Mary Claire Day tried to contact me by phone but left a voice mail for me and sent an email.  I am going to try to call her back because I would like a two-way conversation.  I think she contacted more because of the email and contact that I had with Pam Gippert than because of the phone message I left her.  Ms. Gippert forwarded my email to Ms. Day.

At this point, the information I received by voice mail and email is sketchy and incomplete.  Dr. Terlecki nor Dr. Atala contacted me.  At this point, I feel like Ms. Day will be my best contact, at least initially.  As I said, I do have some partial answers to my questions, I just want more answers before I unpack for the forum.

My Guess is that Christmas week might slow down and communication for several days.
Title: Re: Wake Forest- Good news
Post by: hope794 on December 30, 2018, 11:30:27 AM
Thanks for your work, Hawk!!
Title: Re: Wake Forest- Good news
Post by: Hawk on December 31, 2018, 06:22:02 AM
It has been a slow process.  The time of the year could account for that.  I am going to call again today but it might be later in the week before I get through.
Title: Re: Wake Forest- Good news
Post by: DELETED on December 31, 2018, 07:50:50 AM
Hawk,

Please ask them the main questions that were wrote in first page of this thread. Thanks.
Title: Re: Wake Forest- Good news
Post by: Hawk on December 31, 2018, 09:31:58 AM
Alex,

You can rest assured of that.  That is the whole reason I asked for submitted questions.  If I am nothing else, I am through, often to the point of annoying people that aren't.  i have already submitted those questions in writing.
Title: Re: Wake Forest- Good news
Post by: DELETED on February 01, 2019, 02:14:59 PM
Hawk,

Any news&updates?
Title: Re: Wake Forest- Good news
Post by: Werther on February 02, 2019, 10:22:54 AM
I was going to bump this thread by myself too.

What happened? Almost two months have passed since you first got in touch with Wake Forest's personnel and Christmas Holidays have long been finished... So? Did you get any form of response?
Title: Re: Wake Forest- Good news
Post by: popopo on February 13, 2019, 01:08:16 PM
Anything new?
Title: Re: Wake Forest- Good news
Post by: Hawk on March 06, 2019, 11:55:53 AM
I have had trouble talking live to anyone (that could answer questions) on numerous attempts.  I am encouraged that they did try to call me once but I missed the call.

Here is some email information that I received from Mary Claire-Day.  This is part of an email that included my questions and their response in red font..

1.  Can WFIRM confirm that the eventual goal of this study is to resolve erectile dysfunction, deformities, curvature, and size loss that are linked to Peyronie's Disease or, more generally, erectile tissue's fibrosis? If you don't intend to confirm that with regards to your phase-1 study - since it's only a safety study - is it your goal to confirm it at least for phase-2? In other words, what's the aim of the whole trial? Is it to solve erectile tissue's fibrosis and resulting side-effects?    THIS IS A SAFETY AND FEASIBILITY STUDY AND WE HOPE TO MOVE ON TO A PHASE 2 FOR OTHER INDICATIONS THAT REQUIRE REPLACING CORPORAL TISSUE

2.  Why does candidates' enrolment for this phase-1 study have to take at least 2 years? What's the reason behind this? Is it like this because of the FDA or is it a WFIRM's choice? Can anyone do anything to reduce the timeline expected for closing candidate enrolment for this phase of the clinical trial? If so, specifically what can be done?  Can we help?   WE ARE REQUIRED BY THE FDA TO STAGGER ENROLLEMENT – WE ARE REQUIRED TO WAIT 3 MONTHS IN BETWEEN PATIENTS TO ENSURE THAT THERE ARE NO ADVERSE EVENTS.  THE FDA ALSO REQUIRED THE 3 YEAR FOLLOW-UP PERIOD

3.  What about the "whole penis development"'s project? WFIRM announced to the media that they were able to create "half a dozen human penises" back in 2014 (here's the link: https://www.theguardian.com/education/2014/oct/04/penis-transplants-anthony-atala-interview [theguardian.com]) but it is taking many years just to replace small parts of erectile tissue? Will you ever be able to bioengineer the whole organ? And why was there a report that you did this in a lab years ago?  Was this accurate or was it simply hyped media reporting?   WE ARE REQUIRED BY THE FDA TO SHOW SAFETY IN STEPS (CORPORA, URETHRA) BEFORE WE MOVE FORWARD WITH A WHOLE PENIS SURGERY.  I DO NOT HAVE ANY MORE INFORMATION THAN THIS

4.  What kind of adverse events do they think can happen with this experimental procedure? Are you able to provide a full list of possible adverse events?  I AM HAVING TROUBLE SENDING ATTACHMENTS WITH MY EMAIL BUT WILL TRY TO SEND YOU A COPY OF THE CONSENT FORM SO THAT YOU CAN SEE THE POTENTIAL ADVERSE EVENTS – THE LIST OF ADVERSE EVENTS WAS ALSO, IN PART, DICTATED BY THE FDA  Guys, See the "RISKS" document that I attached below these questions

5.  What are the causes of the constant delays with this trial?  a member reports he was once told by Ms. Day that they had to begin with enrolment last May, then - after another email's contact - she reported they would have begun enrolling people by June or July; now we read on clinicaltrials.gov [clinicaltrials.gov] that you are not recruiting yet. What's the reason for this? When are actually going to recruit candidates?  Can we help?   THE DATES WERE ESTIMATES – WE HAVE BEEN WAITING FOR ALL ADMINISTRATIVE APPROVALS TO BEGIN AND ARE NOW WAITING FOR OUR LAB TO TELL US WE CAN BEGIN.  I HAVE BEEN TOLD THAT WE SHOULD BE ABLE TO RECRUIT STARTING IN FEBRUARY, BUT I AM AT THE MERCY OF THE LAB

6.  Does WFIRM have an approximate timeline with deadlines for the whole trial? Can you estimate when you will begin phase-2 and phase-3 and when you will be completely finished with this?   How many years will it take for all of the tests, trials, and approvals before this technology finally will be available in clinical practice? What is the most optimistic hope for availability to the patient (5 years, 10 years, 20 years)?  (We ask because men are actually delaying implant and other surgeries in the hope that this will become available as a better solution.)  NO WE DO NOT HAVE A TIMELINE. IT MAY TAKE UP TO 5 YEARS TO COMPLETE THE PHASE 1 WITH THE 3 YEAR FOLLOWUP INCLUDED.  WE PLAN TO SUBMIT THE PHASE 2 TO THE FDA PRIOR TO THE COMPLETION OF ALL THE FOLLOW-UP.  ANY FUTURE STUDIES WILL BE MULTICENTER SO THAT ENROLLMENT MAY BE QUICKER

_____________________________________________________________________________________________________________________________________________

What Are the Risks of the Study?


Being in this study involves some risk to you. You should discuss the risk of being in this study with the study staff. It is important to note that if you take part in this study and experience an adverse event, it may limit or eliminate the possibility of having a future treatment or surgery for that condition because of infection or deformity.   



Risks and side effects related to the biopsy and corpora cavernosa construct treatment that we are studying include (but are not limited to):



Anesthesia Risks

Your will be placed under conscious sedation (made very relaxed and/or sleepy with medication but not put completely to sleep) and/or general anesthesia (put completely to sleep with medication) twice - once for the biopsy and once for the corpora cavernosa construct implant procedure.  If you were not enrolled in this study, and underwent the current standard of care surgical treatment, you would also receive anesthesia once as part of that treatment.  While under anesthesia, you could have difficulties breathing requiring emergency care to help you breathe, or she could have serious cardiac dysrhythmias (abnormal heartbeats), changes in liver, nausea, vomiting, itching, stroke, or suffer brain damage or death.  These are complications that can occur with any operative procedure. Dr. Terlecki, or a member or the study team, will discuss with you these general surgical and anesthesia risks.  These risks will also be explained before your surgery in a separate consent form provided by Wake Forest Baptist Health that you will be asked to sign.  A copy of that consent form will be placed in your medical and study records.



Risks Associated with the Biopsy and Implant Surgeries

·         Pain, bleeding that is hard to stop, infection at the site of the biopsy and/or the corpora cavernosa construct implant.



We may not be able to obtain the corpora tissue/cells from the biopsy due to unexpected and unforeseeable (not currently thought of) technical reasons, the cells may not become part of the scaffold as expected or at all, or the implanted corpora cavernosa construct may fail and have to be removed. If any of these occur, you may choose to receive standard of care surgery or other options at a later date.


Potential risks that are similar to the standard-of-care penile prosthesis implant procedure include:
pain which may be temporary or long term
infection which could require antibiotics and/or result in loss of penile tissue and/or the construct implant
damage to surrounding tissue (blood vessels, nerves, muscles) requiring immediate or delayed surgical repair
injury to the urethra, urethral stricture and/or abnormal voiding which may require temporary or permanent catheter
penile abscess or fistula formation which would require additional surgery and possible catheter placement
injury to the rectum which would require additional corrective surgery
continued or worse erectile dysfunction  which may require medication or another surgery
penile curvature which may require surgery or may not be able to be corrected


Blood Draw Risks

Pain, bruising, bleeding that is hard to stop, infection at the site from which the blood is drawn, and fainting may result from the blood draws at any of the visits.


X-Ray/Radiation Risks

Exposure to x-rays if you have the chest x-ray at screening .You will be exposed to amounts of radiation above what you would normally receive in daily life. To be sure that you do not receive an unhealthy amount of radiation from participation in this study, you should let the study doctor know if you have had, or are going to have, any other scans or x-rays as part of your medical or dental care. It is very important that you let the study doctor know if you are already participating in, or plan to participate in, any other research study that involves radiation exposure.



Risks Associated with the Scaffold

Because the cells used on the scaffold will be your own (also known as Autologous), we do not expect any bad reactions that could occur if someone else's cells would be used (also known as Allogeneic), but there is always a small risk of an allergic-type reaction which may lead to the need for the implant to be removed.


There is a risk of infection from bacteria and other disease causing agents that may be accidentally introduced during the process of creating the scaffold/construct.   The entire procedure will take place within the sterile environment so this is not expected. 


There is a risk that any improvement in function that you may have following the treatment may not be permanent.  Some of the early studies that were performed in rabbits have shown that penile function improvement began to fade after about 6 months.


Confidentiality Risk

There is a slight risk of a breach of confidentiality.  Taking part in this research study may involve providing information that you consider confidential or private.  Efforts, such as coding research records, keeping research records secure and allowing only authorized people to have access to research records, will be made to keep information safe.


Other Risks

There also may be other side effects that we cannot predict. You should tell the research staff about all the medications, vitamins and supplements you take and any medical conditions you have. This may help avoid side effects, interactions and other risks.


A Data Safety and Monitoring Committee, an independent group of experts, will be reviewing the data from this research throughout the study.


Other Issues to Participating in Research


As part of this study, you will be tested for HIV (human immunodeficiency virus, which is the virus that causes the acquired immunodeficiency syndrome [AIDS]); Hepatitis B and C, and other infectious blood diseases/viruses. You will be told of the results of the testing, and counseled as to the meaning of the results, whether they are positive or negative. If the test indicates that you are infected with any of these diseases, you will receive additional counseling about the significance of your care and possible risks to other people. We are required by law to report all positive results of these tests to the North Carolina State Board of Health. The test results will be released only as permitted by applicable law. If you do not want to be tested for HIV, Hepatitis B or C or other infectious diseases, you should not agree to participate in this study.  If any of the tests are positive, you will be excluded from the study.

Title: Re: Wake Forest- Good news
Post by: Hawk on March 06, 2019, 05:03:25 PM
From my read, it could be 15 years or more before extensive replacement of organ components is available, assuming the trials are actually successful.
Title: Re: Wake Forest- Good news
Post by: Pfract on March 07, 2019, 10:17:20 AM
One of the best bits on information on this topic, the reply above. Thank you hawk!
Title: Re: Wake Forest- Good news
Post by: DELETED on March 07, 2019, 01:50:14 PM
Thanks for information Hawk.

15 years... in other words it's over.
Title: Re: Wake Forest- Good news
Post by: Hawk on March 07, 2019, 03:50:52 PM
What's over?

I am guessing but it looks like up to 5 years just for phase 1 and all of this assumes that everything progresses without any significant setbacks.

I think this research (and all organ regeneration research) is very positive for future patients.  My personal view is that anyone that is planning to forgo 10 or 15 years of a sexually capable life waiting on this has to be wired far differently than I am both from a standpoint of thought process and sex drive.  There are solutions now.  All solutions suggest there is a problem.  No solution is as convenient as not having a problem to begin with but the solutions range from being easily attainable to requiring a major financial commitment depending on your location, your finances, medical insurance, and access to the right doctors.
Title: Re: Wake Forest- Good news
Post by: Jack1909 on March 08, 2019, 07:53:52 AM
There s no a solution for everyone...I repeat, maybe I'm the only one on this board but I dont think I'm the only one in the world..people like me with massive neuropathy and pain are often rejected from implant specialists.

Same thing goes for people in their twenties....with the all duty respect Hawk, but you are more than 60. A 25 years old putting an implant needs to take into account things you don't..

I dont see how this needs to take so long, never heard about a phase 1 lasting so much..the technology is already here, it must be something else....

This why we need to act together and take this over, because this is about us. Not about Terlecki nor this Marie.

Otherwise we can die, right away. Casted out by the hypocrisy of the society we live in.
Title: Re: Wake Forest- Good news
Post by: Jack1909 on March 08, 2019, 07:59:07 AM
2 plus 3 years of follow up is a ridiculous term imposed by FDA...with all the crap surgeons are allowed to put into patients..ridiculous terms by a ridiculous agency. We need the same research in a country like Japan..

Title: Re: Wake Forest- Good news
Post by: Pfract on March 08, 2019, 02:56:07 PM
@Jack:

Waiting 15 years for a cure that might not come, especially when you have solutions now that work and allow you to have a healthy sex life is just Dumb. I may not be 25, but I was 27 when I fractured my penis and I am now 32. I find the implant super reasonable, and I am not alone. Nothing beats a normal penis, but in the absence of that... Wait till you are 45/50 just because you refuse to see what's in front of you is just ridiculous.

And also, trials and waiting time exist for a very important reason. In this case, imagine going for a graft developed by wake forest to solve your fibrosis and end up loosing your penis because of some unpredictable issue? Can't you see that?
Title: Re: Wake Forest- Good news
Post by: Jack1909 on March 08, 2019, 03:13:05 PM
Prfact you have been telling this for 5 years but you have not already gone for an implant. What are you waiting for..please dont tell us you are saving money. The question is if you are saying what you are saying as you want to convince us or you are trying to convince yourself.

I already told you I have been rejected by an implant specialist who told me putting an implant in my condition would be insane. So...i need to jump out of the window that's the conclusion.

The fact is many guys are solution less and that's outrageous.
Title: Re: Wake Forest- Good news
Post by: Jack1909 on March 08, 2019, 03:16:50 PM
You can lose your penis even going for an implant surgery, you can die as well..come prfact, be serious. There are far more people suffering from huge complications from routine surgeries than people actually harmed by trials.. I'm one of them.
Title: Re: Wake Forest- Good news
Post by: DELETED on March 08, 2019, 03:37:35 PM
pfract,

I have to agree with Jack1909. You keep telling this for years and technically it's nothing other than "mental masturbation", in your case it's about implants that you constantly delay year after year. If implants are so great, why don't you haven't it done already? From your description: "Penile fracture during sex, Portugal, August 2014 (no surgical repair, left with moderate Erectile Dysfunction)"

What are you waiting for almost 5 years, when the solution is right there? I bet there's a chance that in the next few years you still will be posting here with a description under your post changing every year:

"Implant surgery 2026? 2028? 2030?"
Title: Re: Wake Forest- Good news
Post by: Hawk on March 08, 2019, 04:22:33 PM
Quote from: Jack1909 on March 08, 2019, 07:53:52 AM
There s no a solution for everyone...Same thing goes for people in their twenties....with the all duty respect Hawk, but you are more than 60. A 25 years old putting an implant needs to take into account things you don't..

I dont see how this needs to take so long, never heard about a phase 1 lasting so much..the technology is already here, it must be something else....

This why we need to act together and take this over, because this is about us. Not about Terlecki nor this Marie.

Jack, you are absolutely correct.  There are few if any solutions that are good for everyone regardless of their health issue.  Leading high volume surgeons routinely perform implant surgery on men in their 20's however and even in their teens.  There are very few teens that would prefer a non-working penis to an implant.  Most that get an implant consider it as good as their natural penis in their prime.  Xehonart just got an implant and just turned 30 years old so age has little to do with the decision unless you are too unhealthy for an implant.  In that case, a man would likely be too unhealthy for regeneration treatment as well, especially while the treatment is still in trial.

They are not going to speed this and no one is going to take over the FDA.  There are risks.  Nothing about this is a guarantee.  They are not experimenting on mice dicks.  They are using men.  The same people that want them to rush are the ones that would sue them if their penis was damaged even more from the treatment.
Title: Re: Wake Forest- Good news
Post by: Werther on March 08, 2019, 05:13:45 PM
Thanks for the report Hawk.

I have to say that I'm pretty disappointed though. The unavailabilty of the people from Wake Forest tells a lot about their credibility: during the course of three months NOBODY was available to talk live... That's ridiculous.

The answers you were given were ridiculous too.

They didn't answer the first question at all (the most important one), even if you correctly pointed out that we all know that, being a phase-1 trial, its only purpose will be to determine if their procedure is safe or not. Nonetheless there's no reasonable motive to omit what do they expect from the surgery (i.e. why should it be performed on the people who're listed in their record instead of the current available procedures).

Then, what does the answer to question n. 5 even mean? What's this dictatorial "lab" Ms. Day is referring to? Is there some sort of masonic circle within their Institute that deliberately keeps postponing this trial just for the fun of doing it without even communicating the reason for this choice to their public referent? LOL. Does this Ms. Day really think that people contacting her are all a bunch of retards? She could have at least stated that she's not authorized to give these information. At least she wouldn't have made a fool of herself.

Besides I was already skeptical on their claims about the fact that they were able to create "whole penises". Now I'm sure they actually didn't: even the response to question n. 3 in fact doesn't make any sense at all: there's people who completely lost their dick and they don't need to wait for "step by step" processes; as a matter of fact they're being offered allogenic transplants by these people (https://clinicaltrials.gov/ct2/show/NCT03240822). If Atala was actually able to grow complete dicks from stem cells the trial for these people would be dealing with these organs rather than donors' ones.

The only useful and new piece of information that was revealed by this response is the attached informed consent. What we came to know is anything but promising however:

QuoteThere is a risk that any improvement in function that you may have following the treatment may not be permanent.  Some of the early studies that were performed in rabbits have shown that penile function improvement began to fade after about 6 months

They never told the public that this experimental surgery wasn't successful in the long term.


As I said in the beginning, I'm pretty disappointed. BTW at least we now know how shallow these WFIRM's guys actually are...
Title: Re: Wake Forest- Good news
Post by: Jack1909 on March 08, 2019, 05:17:09 PM
I won't respond as it would be useless..you are polluting any thread of this forum with implants advertising. All the right to do it, but people have eyes.

And yes, people with issues on penis should are not allowed to have regenerative therapies on it. LOL

Title: Re: Wake Forest- Good news
Post by: Pfract on March 08, 2019, 07:14:47 PM
I like all these childish comments from Jack909 and Alexsamo, like spoiled little teens that cannot hear anything other than what they want.

But yes, I am saving money and paying bills and building my professional career in the process too. I was living in Portugal, fractured my penis in 2014, went broke financially asking doctors for help, emigrated to Canada in 2015, started life from zero, saved money and went to doctor Goldstein in 2016 to see if I was candidate for his surgery (penile revascularization) which is why I did the ultrasound there. The answer was no, so I started saving for the implant.

If you actually researched other treatments other than fantasy treatments that will come in 30 years, you would know that implants out of pocket in the USA cost between 25/30.000$ CAD. And then add some more for flights and hotels and what not. THAT IS A LOT OF MONEY THAT TAKES TIME TO SAVE!

If you were mature enough mentally you would know that and that life gets in the way as well, but no. Nothing but a cocky little trouble maker gets angry because people tell you that an implant is an option.

Why haven't you called Dr eid by phone appointment yet to tell him your beautiful story of how you were denied an implant? Why's that?

Grow up man
Title: Re: Wake Forest- Good news
Post by: Jack1909 on March 09, 2019, 01:16:36 AM
cocky POS, well...LOL couldn't expect anything better from you.
Title: Re: Wake Forest- Good news
Post by: Patientxyz1992 on March 09, 2019, 11:46:51 AM
Hello guys my toughts are next,if they really develop this as patentable technology i think that whole replacement of corpora would be even easier than replacing a part of it,what you think?also i must say that even if implants are not perfect solution they are superior to anything else and personaly if i wouldnt have usable erection i would go with implant asap,if your leg somehow got choped off would you wait 20 years so maybe technology would replace it or would you put prosthetic on and start running?even if technology of regrowing will exist in near future i doubt it will be used becouse implants,pills and other stuff are very profitable,also  i think if they figure out how to regrow corpora,soon enough they will find out how to be immortal which is in my eyes very foolish and distant hope.......i hope im wrong...
Title: Re: Wake Forest- Good news
Post by: DELETED on March 09, 2019, 11:50:17 AM
pfract,

Yeah bruh, keep coping. When did you say you will get implants? In 2025 or in 2030 or maybe 2040? How much did you saved? Like 10 bucks per year? Anyway, implants are best. Keep talking your mantra every day bruh.

QuoteIf you actually researched other treatments other than fantasy treatments that will come in 30 years
Why then you're posting in this thread if this is a "fantasy treatments that will come in 30 years"? This thread about tissue engineering, but you keep spreading your everyday mantra's about implants. Please do all of us a favor - choose other thread for spamming.

Post edited by Moderator- Name calling and other hostile attacks will not be tolerated - OFFICIAL WARNING ISSUED

Title: Re: Wake Forest- Good news
Post by: Hawk on March 09, 2019, 12:01:07 PM
I am a cancer survivor that will likely die of cancer even though at the moment I am healthy, symptom-free, and fit.  I do have cancer, however, and I follow tons of promising research with the hope that if I last long enough maybe there will be a treatment that is not just as bad as the cancer can be (far worse than the cancer is now).  I see how long these "promising new therapies" take and how limited their success is.  News media love to hype them either out of ignorance or sensational reporting to make a good story.  I am sure this same scenario exists in all medical circles, at least in the U.S. 

As far as "advertising for implants" that is stupid.  I have been here for 15 years trying everything from traction, VED, thousands of dollars in supplements, PDE5 inhibitors, Trazadone, manual stretching, and snake oil.  I feel stupid for all of it at this point and the same motivation that made me create this forum and spend thousands of hours and dollars is what makes me spread what to me and others is good news.  Call it advertising if you like.  I am sure like a smoker that finally accomplishes something by quitting, I annoy other smokers by preaching the word.  If you find a solution that makes you as happy as you were in your prime you will do the same.  The difference is that you will be welcome to do so on a forum that I pay for and that is maintained by the likes of me Pfact and others.  We will work to give you a forum to spread news of your solution without insults, accusations, or attacks like the ones that you like to direct at me.  It does not make you look either wise or mature.

Now, an end to the insults and back to the discussion on Wake Forest organ regeneration.

PS: Patientxyz1992 express my sentiments exactly.
Title: Re: Wake Forest- Good news
Post by: TonySa on March 09, 2019, 12:29:09 PM
Alexsammo, I found your language of "like a toxic faggot" very offensive.  You should apologize, remove it from your post and not use hate speech any further.  I speak only for myself.

Title: Re: Wake Forest- Good news
Post by: Jack1909 on March 09, 2019, 01:18:34 PM
TonySa Prfact with no reason called me and AlexSamo cocky piece of crap...isn't this offensive..why no one moderated that.
Title: Re: Wake Forest- Good news
Post by: Hawk on March 09, 2019, 01:30:26 PM
Jack,

It is time for you to put a lid on it.  If you have further comments that are not directly about Peyronies Disease or ED they best be made to me with a personal message

Hawk
Title: Re: Wake Forest- Good news
Post by: Hawk on March 09, 2019, 01:34:19 PM
Quote from: Keith Walts on March 09, 2019, 01:30:13 PM

So 15 years for the Wake Forest thing best case scenario? Oof  :-\

I don't think anyone said 15 years is the best case scenario.  I think that was my uneducated guess from the limited data I got from them that it could be that long.  That was a guess based on - they said 5 years for phase one.  In reality, this might not happen in a century and I guess could happen in 9 or 10 years if everything goes perfectly.
Title: Re: Wake Forest- Good news
Post by: Patientxyz1992 on March 09, 2019, 02:59:22 PM
Lets assume that they can make new corpora for people suffering from this disease, i will make a guess that implanting it in the penis would be as difficult or more than making new one,thats my fear!
Title: Re: Wake Forest- No Good news
Post by: suicidecomingsoon on March 10, 2019, 06:47:27 AM
It's a pipe dream.
At the pace that advances wake forest this technology will not be offered even in 15-20 years from now and that if all goes ok. F~@<


Title: Re: Wake Forest- Good news
Post by: Werther on August 18, 2019, 05:42:56 PM
Jack, your inbox is full! Please delete some itmes!
Thank you.
Title: Re: Wake Forest- Good news
Post by: drew67 on February 12, 2020, 01:52:50 PM
any update on this?
Title: Re: Wake Forest- Good news
Post by: TonySa on February 12, 2020, 02:43:34 PM
Don't count on wake forest treating peyronies anytime soon...
Title: Re: Wake Forest- Good news
Post by: Tobyg on February 13, 2020, 12:01:15 AM
reading all this is a hard blow, I had hopes in "wake forest", I thought that regenerative medicine was advanced, I have no curve, but my dysfunction affects me a lot.
How horrible is this life.
Title: Re: Wake Forest- Good news
Post by: TonySa on February 13, 2020, 11:36:29 AM
What kind of dysfunction are you experiencing?
Title: Re: Wake Forest- Good news
Post by: Pfract on February 13, 2020, 12:25:03 PM
What amazes me to this day, is how people are still counting on Wake Forest to help them out in their life time. I have no doubt they are doing amazing things, and that their job will help out a lot of people. But sitting here waiting for something from them, that may never possibly come is just crazy.... To each is own, i guess.
Title: Re: Wake Forest- Good news
Post by: Tobyg on February 13, 2020, 05:30:18 PM
@TonySa: I have 2 hard areas, before the glans (the glans are not erect to the maximum) and the other at the base, below the penis (this is the worst, I can not keep the erection complete, my spongy body deflates due to loss of elasticity , also brought me problems on the pelvic floor, I did a little traction and something improved but it does not seem to be solved, my other problem is circumcision that made me lose sensitivity and affects my erections too.

@pfract: what is your idea, I tried almost everything, I do not rule out studying tissue histology, but I think it will be useless.
Title: Re: Wake Forest- Good news
Post by: peter123 on October 02, 2020, 11:02:57 AM
Quote from: Jack1909 on March 08, 2019, 05:17:09 PM
I won't respond as it would be useless..you are polluting any thread of this forum with implants advertising. All the right to do it, but people have eyes.

And yes, people with issues on penis should are not allowed to have regenerative therapies on it. LOL
you are the definition of pollution seriously, look hoe you messed up this thread
Title: Re: Wake Forest- Good news
Post by: Olive on October 02, 2020, 11:24:51 AM
Boys, don't fight. Santa Claus won't bring you a straight dick if you're naughty!
Title: Re: Wake Forest- Good news
Post by: Werther on February 20, 2021, 11:44:37 PM
UP

Have there been any progress with regards to the use of this procedure (if anyone know)?
Title: Re: Wake Forest- Good news
Post by: Christopher1 on April 01, 2021, 03:10:52 AM
Bump